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Abbott (ABT) Aveir System Meets Primary Pivotal Trial Endpoints
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Abbott Laboratories (ABT - Free Report) recently announced new, late-breaking data from the Leadless II IDE study assessing Abbott's investigational Aveir leadless pacemaker in patients with certain abnormal heart rhythms. The study findings were presented in a late-breaking session at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society (APHRS).
The study data demonstrate that the Aveir device met its pre-specified primary endpoints and suggest that the Aveir system could offer new benefits for patients who need pacemakers to treat slow heart rhythms once approved.
The recent development is likely to fortify Abbott’s Cardiac Rhythm Management business.
More on Aveir System
Abbott's Aveir system is the only leadless pacemaker in the world specifically developed to be retrieved when the device needs to be replaced or if a patient's therapy needs to be changed.
Currently, Abbott's investigational Aveir leadless pacemaker is being evaluated for FDA approval.
More on LEADLESS II STUDY
The Leadless II IDE study is a prospective, non-randomized, multicenter study intended to assess the clinical safety and efficacy of the Aveir leadless pacemaker in patients who were indicated for a VVI(R) or ventricular demand pacing pacemaker, which stimulates the heart only if the heart rate falls below a set level.
Under the Leadless II trial study, primary safety and efficacy endpoints were evaluated in the 200 patients enrolled in 43 centers in the United States, Canada and Europe and were followed for six weeks.
Study Outcomes
The study data demonstrates the successful implant of the Aveir leadless pacemaker in 98% of patients. At six weeks post-implant, 96% of patients met the safety endpoint of no serious adverse device effects and 95.9% achieved the efficacy endpoint of acceptable therapy provided to the patient.
Image Source: Zacks Investment Research
In addition, in 96% of clinical cases, physicians were able to accurately position the device either the first time or with a single repositioning.
Significance of the Aveir System
Per Abbott’s management, the results of the Leadless II study are a strong indicator that once the device is approved, the Aveir system can help physicians manage the care of patients with certain abnormal heart rhythms. The new Aveir pacing system has the potential to advance treatment for patients who need a pacemaker but where physicians are concerned about more invasive surgery.
The rise in the number of eligible patients, preference for new technology, growing geriatric population and rising number of cardiovascular diseases are driving the market.
Recent Developments
In September 2021, Abbott announced the receipt of the FDA approval for its Amplatzer Talisman PFO Occlusion System to treat people with a patent foramen ovale (PFO) – a small opening between the upper chambers of the heart – who are at risk of recurrent ischemic stroke.
In the same month, Abbott announced the receipt of the FDA approval for the company's Epic Plus and Epic Plus Supra Stented Tissue Valves to improve therapy options for people with aortic or mitral valve disease.
Price Performance
Shares of the company have gained 13% in a year against the industry’s fall of 1.3%.
Thermo Fisher Scientific, carrying a Zacks Rank #2 (Buy), reported third-quarter 2021 adjusted earnings per share (EPS) of $5.76, which surpassed the Zacks Consensus Estimate by 23.3%. Revenues of $9.33 billion outpaced the Zacks Consensus Estimate by 12%.
Thermo Fisher has an estimated long-term growth rate of 14%. TMO surpassed estimates in the trailing four quarters, the average surprise being 9.02%.
LabCorp reported third-quarter 2021 adjusted EPS of $6.82, which surpassed the Zacks Consensus Estimate by 42.9%. Revenues of $4.06 billion outpaced the Zacks Consensus Estimate by 13.4%. It currently carries a Zacks Rank #2.
LabCorp has an estimated long-term growth rate of 10.6%. LH surpassed estimates in the trailing four quarters, the average surprise being 25.7%.
Medpace reported third-quarter 2021 adjusted EPS of $1.29, surpassing the Zacks Consensus Estimate by 20.6%. Revenues of $295.57 million beat the Zacks Consensus Estimate by 1.2%. It currently carries a Zacks Rank #1.
Medpace has an estimated long-term growth rate of 16.4%. The company surpassed estimates in the trailing four quarters, the average surprise being 11.9%.
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Abbott (ABT) Aveir System Meets Primary Pivotal Trial Endpoints
Abbott Laboratories (ABT - Free Report) recently announced new, late-breaking data from the Leadless II IDE study assessing Abbott's investigational Aveir leadless pacemaker in patients with certain abnormal heart rhythms. The study findings were presented in a late-breaking session at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society (APHRS).
The study data demonstrate that the Aveir device met its pre-specified primary endpoints and suggest that the Aveir system could offer new benefits for patients who need pacemakers to treat slow heart rhythms once approved.
The recent development is likely to fortify Abbott’s Cardiac Rhythm Management business.
More on Aveir System
Abbott's Aveir system is the only leadless pacemaker in the world specifically developed to be retrieved when the device needs to be replaced or if a patient's therapy needs to be changed.
Currently, Abbott's investigational Aveir leadless pacemaker is being evaluated for FDA approval.
More on LEADLESS II STUDY
The Leadless II IDE study is a prospective, non-randomized, multicenter study intended to assess the clinical safety and efficacy of the Aveir leadless pacemaker in patients who were indicated for a VVI(R) or ventricular demand pacing pacemaker, which stimulates the heart only if the heart rate falls below a set level.
Under the Leadless II trial study, primary safety and efficacy endpoints were evaluated in the 200 patients enrolled in 43 centers in the United States, Canada and Europe and were followed for six weeks.
Study Outcomes
The study data demonstrates the successful implant of the Aveir leadless pacemaker in 98% of patients. At six weeks post-implant, 96% of patients met the safety endpoint of no serious adverse device effects and 95.9% achieved the efficacy endpoint of acceptable therapy provided to the patient.
In addition, in 96% of clinical cases, physicians were able to accurately position the device either the first time or with a single repositioning.
Significance of the Aveir System
Per Abbott’s management, the results of the Leadless II study are a strong indicator that once the device is approved, the Aveir system can help physicians manage the care of patients with certain abnormal heart rhythms. The new Aveir pacing system has the potential to advance treatment for patients who need a pacemaker but where physicians are concerned about more invasive surgery.
Industry Prospects
Per a report by Persistence Market Research, the global leadless pacing systems market size was $29.4million in 2017 and is projected to see a CAGR of 10.0% by 2025.
The rise in the number of eligible patients, preference for new technology, growing geriatric population and rising number of cardiovascular diseases are driving the market.
Recent Developments
In September 2021, Abbott announced the receipt of the FDA approval for its Amplatzer Talisman PFO Occlusion System to treat people with a patent foramen ovale (PFO) – a small opening between the upper chambers of the heart – who are at risk of recurrent ischemic stroke.
In the same month, Abbott announced the receipt of the FDA approval for the company's Epic Plus and Epic Plus Supra Stented Tissue Valves to improve therapy options for people with aortic or mitral valve disease.
Price Performance
Shares of the company have gained 13% in a year against the industry’s fall of 1.3%.
Zacks Rank and Key Picks
Abbott currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the broader medical space are Thermo Fisher Scientific Inc. (TMO - Free Report) , Laboratory Corporation of America Holdings, or LabCorp (LH - Free Report) and Medpace Holdings, Inc. (MEDP - Free Report) . You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Thermo Fisher Scientific, carrying a Zacks Rank #2 (Buy), reported third-quarter 2021 adjusted earnings per share (EPS) of $5.76, which surpassed the Zacks Consensus Estimate by 23.3%. Revenues of $9.33 billion outpaced the Zacks Consensus Estimate by 12%.
Thermo Fisher has an estimated long-term growth rate of 14%. TMO surpassed estimates in the trailing four quarters, the average surprise being 9.02%.
LabCorp reported third-quarter 2021 adjusted EPS of $6.82, which surpassed the Zacks Consensus Estimate by 42.9%. Revenues of $4.06 billion outpaced the Zacks Consensus Estimate by 13.4%. It currently carries a Zacks Rank #2.
LabCorp has an estimated long-term growth rate of 10.6%. LH surpassed estimates in the trailing four quarters, the average surprise being 25.7%.
Medpace reported third-quarter 2021 adjusted EPS of $1.29, surpassing the Zacks Consensus Estimate by 20.6%. Revenues of $295.57 million beat the Zacks Consensus Estimate by 1.2%. It currently carries a Zacks Rank #1.
Medpace has an estimated long-term growth rate of 16.4%. The company surpassed estimates in the trailing four quarters, the average surprise being 11.9%.